Standardize the intake, triage, case management,
and submission process of ICSRs. Validated in the cloud.
 

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AE STAGING
AgilePV’s workflow-driven global platform facilitates the standardization of the intake, triage, case management, and submission process of Individual Case Safety Reports (ICSR). With AgilePV’s Adverse Events Tracking solution, you can reduce the time and effort involved in processing Adverse Events from start to finish, while maintaining a secure audit trail that can be published with the click of a button.

 
 
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EFFICIENT CASE INTAKE
Replace your paper-based, manually intensive, and error prone data entry process with an automated web-based and mobile platform. Capture case information from any device and attach documentation. Ensure data integrity through field checks and strict access rights.

 
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SEAMLESS INTEGRATION
Generate E2B (R2, R3) verified transmissions to FDA, ICH, EMA, Argus, ArisG, and more. Seamlessly integrate with your home-grown and COTS safety systems. Initiate reports from any device to quickly respond to regulator requests.


AE INBOX
Keep your reports digital with AE Inbox—quickly scan through emails, attachments, and faxes to send adverse event data directly to Staging.

Your intake personnel will never have to print reports, retype information, or overwrite each other’s work ever again.

 
 

AUTOMATED CASE SCORE
Using Natural Language Processing, automatically score the likelihood that communications coming into your intake email address, fax number, and other unstructured data sources, are adverse event reports. Scoring communications makes it easier to know what is awaiting processing.

 
 

INTAKE QUESTIONNAIRES
Rapidly capturing information from any tablet or mobile device will increase the likelihood of you receiving AEs both quickly and accurately.

Now you can define adverse event process rules, and generate customized interactive surveys for case-specific details.  All your processors need is basic internet access.

Tailor AE intake questionnaires to your specific products to make sure processors ask the right questions every time. The case processor will then be able to administer custom surveys or other routine health questions during intake.

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Our users have expressed a high level of comfort using the modules and the general feedback is that the system is easy to learn and use.
— Top 10 Global Pharma Client
 

Request Our AE Case Processing Whitepaper

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